Sage, Biogen: Zuranolone Hits Key Goals in Postpartum Depression

By Colin Kellaher

Sage Therapeutics Inc. and Biogen Inc. on Wednesday said a Phase 3 study of their antidepressant drug candidate zuranolone in women with postpartum depression met its main endpoints.

The companies said zuranolone showed a statistically significant and clinically meaningful improvement in depressive symptoms at day 15, the primary endpoint, and at the key secondary endpoints of days 3, 28 and 45.

Sage and Biogen also said zuranolone was generally well-tolerated and showed a safety profile consistent with prior studies

Sage and Biogen, both based in Cambridge, Mass., late last year signed a global collaboration and license agreement to jointly develop and commercialize zuranolone for major depressive disorder, postpartum depression and other psychiatric disorders.

The companies last month said they had initiated a rolling submission of a new-drug application with the U.S. Food and Drug Administration for zuranolone in the treatment of major depressive disorder and plan to complete the filing in the second half of the year.

Sage and Biogen said they plan an associated filing for postpartum depression early next year.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

June 01, 2022 07:06 ET (11:06 GMT)

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